Background
The etiology of asthma is currently unknown. It has been shown, however, that Chlamydia pneumoniae infection is associated with asthma. Preliminary open-label and randomized trials suggest a positive effect of antibiotics on asthma symptoms. A pilot randomized controlled trial (RCT) indicated positive symptom improvement 3 months after completing 6 weeks of azithromycin treatment, but no effect on C. pneumoniae antibody levels was found. This current study is a RCT designed to investigate whether a 12-week course of azithromycin will improve asthma clinical status up to one year after treatment.
Study Question
Does azithromycin improve asthma symptoms, asthma medication use, exacerbations and quality of life among adult asthma patients typically encountered in clinical practice, and does the improvement persist after treatment is completed?
Intervention
The study will provide tablets of azithromycin or matching placebo to participants for 3 months: one tablet daily for 3 days, then one tablet each week for 11 weeks. Each tablet contains 600 mg azithromycin or matching placebo.
Measurement
Research staff collect demographic and asthma-related information during the patient’s baseline visit. Follow-up information is collected in Internet surveys on a predetermined schedule. Such surveys may be completed directly by the subject or conducted over the telephone with the subject by trained study personnel. Information collected includes asthma symptoms, medication use, control, exacerbations, quality of life and adverse events ongoing for 12 months after randomization.
Eligibility
- Age 18 or older
- English literate with telephone OR email and Internet access
- Physician-diagnosed asthma that is persistently symptomatic, or in exacerbation; plus objective evidence for reversible airway obstruction by spirometry or by peak flow within 2 years of enrollment
Population
At least 6 adult patients from clinics at Aurora Sinai Medical Center and St. Luke’s Medical Center.
Timeline
Participants take study medication for a period of 12 weeks. Survey follow-up for subjects continues for one year (online or by telephone). Study recruitment is slated to end in August 2009. Data collection will end one year after the last patient is enrolled in the study.
Funding Sources
- American Academy of Family Physicians Foundation
- Wisconsin Academy of Family Physicians
- Wisconsin Network for Health Research (WiNHR)
- Pfizer (in-kind supply of study drug)
Supporting Network Information
The Wisconsin Research and Education Network (WREN) and the Wisconsin Network for Health Research (WiNHR) provide support for this research. These organizations are integral components of the University of Wisconsin School of Medicine and Public Health Institute for Clinical and Translational Research.
Local Principal Investigators
Elizabeth Bade, MD
Aurora UW Medical Group
Dennis Baumgardner, MD
Aurora UW Medical Group
Local Participating Clinics
- Aurora Sinai Family Care Center
- Aurora UW Medical Group Family Practice Center located at St. Luke’s
- Aurora Sinai Internal Medicine Clinic
For more information, contact:
Katherine Pronschinske
Milwaukee Area Study Coordinator
(414) 219-7852
katherine.pronschinske@fammed.wisc.edu
Or visit the WREN website at:
http://www.wren.wisc.edu/
For more information on WiNHR, visit:
http://www.cuph.org/winhr
